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A Comparative Clinical Trial Evaluating the Effect and Safety of Tacrolimus Versus Hydrocortisone

Primary Purpose

Dermatologic Disease

Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Tacrolimus ointment
Hydrocortisone 1% cream
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatologic Disease

Eligibility Criteria

2 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female, 2-16 years old AD patients. Exclusion Criteria: patients diagnosed with other skin disorders of serious type and who are taking systemic corticosteroids or anti-inflammatory medications.

Sites / Locations

  • Tanta UnuversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Tacrolimus Group

Hydrocortisone Group

Arm Description

50 patients will be treated with a thin layer of 0.03% topical tacrolimus ointment on the affected areas twice daily for 4 months.

50 patients will be treated with a thin layer of 1% hydrocortisone cream on the affected areas twice daily for 4 months.

Outcomes

Primary Outcome Measures

To compare the impact of topical tacrolimus ointment to topical hydrocortisone cream by measuring inflammatory cytokine levels in the blood.
To compare the impact of topical tacrolimus ointment to topical hydrocortisone cream by measuring inflammatory cytokine levels in the blood such as interleukin-6 (IL-6), and IL-10.

Secondary Outcome Measures

Full Information

First Posted
October 28, 2022
Last Updated
November 2, 2022
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05607901
Brief Title
A Comparative Clinical Trial Evaluating the Effect and Safety of Tacrolimus Versus Hydrocortisone
Official Title
A Comparative Clinical Trial Evaluating the Effect and Safety of Tacrolimus Versus Hydrocortisone in Management of Atopic Dermatitis in Children
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 28, 2022 (Actual)
Primary Completion Date
June 20, 2025 (Anticipated)
Study Completion Date
August 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
One of the most frequent skin conditions is atopic dermatitis (AD), characterized by its pruritic inflammation effect. Where the prevalence of AD increased in the last three decades by two or three folds worldwide, especially in developed countries, AD is supposed to affect about 15% to 30% of children, and 2% to 10% of adults. This type of dermatitis is frequently linked to a family history of other atopic illnesses such as allergic rhinitis or asthma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatologic Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
• A randomized, controlled, and parallel study will comprise 100 patients with AD
Masking
ParticipantInvestigator
Masking Description
double-blinded
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tacrolimus Group
Arm Type
Active Comparator
Arm Description
50 patients will be treated with a thin layer of 0.03% topical tacrolimus ointment on the affected areas twice daily for 4 months.
Arm Title
Hydrocortisone Group
Arm Type
Active Comparator
Arm Description
50 patients will be treated with a thin layer of 1% hydrocortisone cream on the affected areas twice daily for 4 months.
Intervention Type
Drug
Intervention Name(s)
Tacrolimus ointment
Intervention Description
tacrolimus is an immunosuppressive drug acting as an immunomodulator to assist manage acute flares and reducing the severity of future flares
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone 1% cream
Intervention Description
Topical corticosteroids (TCS) are the cornerstone for the management of AD to which other treatments are compared.
Primary Outcome Measure Information:
Title
To compare the impact of topical tacrolimus ointment to topical hydrocortisone cream by measuring inflammatory cytokine levels in the blood.
Description
To compare the impact of topical tacrolimus ointment to topical hydrocortisone cream by measuring inflammatory cytokine levels in the blood such as interleukin-6 (IL-6), and IL-10.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, 2-16 years old AD patients. Exclusion Criteria: patients diagnosed with other skin disorders of serious type and who are taking systemic corticosteroids or anti-inflammatory medications.
Facility Information:
Facility Name
Tanta Unuversity
City
Tanta
ZIP/Postal Code
31527
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eman I Elberri, PhD
Phone
0201003592593
Email
mbahaa@horus.edu.eg
First Name & Middle Initial & Last Name & Degree
Mostafa M Bahaa, PhD

12. IPD Sharing Statement

Learn more about this trial

A Comparative Clinical Trial Evaluating the Effect and Safety of Tacrolimus Versus Hydrocortisone

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